Ignite Creation Date:
2024-05-06 @ 3:09 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02211430
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2014-05-13
Brief Title:
Smoking Cessation for Low-Income Pregnant Women
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Smoking Cessation for Low-Income Pregnant Women
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACS
Brief Summary:
To meet the Healthy People 2010 objective of increasing tobacco abstinence among pregnant women to 90 new methods for treating nicotine addiction among pregnant women are needed To this end we propose to evaluate an innovative cognitive-behavioral smoking cessation intervention for low-income minority women conducted in the prenatal and postpartum phases Considering the strong link between tobacco use and cancer risk the development of effective smoking cessation treatments has important health implications for cancer prevention and control initiatives The aims to be addressed are
Aim 1 To compare an enhanced Cognitive-Behavioral Counseling CBC smoking cessation intervention with a Best Practice control condition BP for reducing smoking rates ie continued abstinence 7-day point prevalence and number of cigarettes smoked in the short- and long-term among pregnant women It is hypothesized that smokers receiving CBC will show reduced rates of tobacco use versus those in the BP over time
Aim 2 To evaluate the impact of the CBC intervention on the hypothesized mediators of behavior change ie heightened risk perceptions enhanced self-efficacy and reduced fatalistic beliefs high pros and low cons of quitting reduced emotional distress It is hypothesized that the psychosocial factors will mediate the effect of the CBC intervention on change of smoking behaviors
Aim 1 To compare an enhanced Cognitive-Behavioral Counseling CBC smoking cessation intervention with a Best Practice control condition BP for reducing smoking rates ie continued abstinence 7-day point prevalence and number of cigarettes smoked in the short- and long-term among pregnant women It is hypothesized that smokers receiving CBC will show reduced rates of tobacco use versus those in the BP over time
Aim 2 To evaluate the impact of the CBC intervention on the hypothesized mediators of behavior change ie heightened risk perceptions enhanced self-efficacy and reduced fatalistic beliefs high pros and low cons of quitting reduced emotional distress It is hypothesized that the psychosocial factors will mediate the effect of the CBC intervention on change of smoking behaviors
Detailed Description:
Rates of Smoking Among Pregnant and Postpartum Women
Despite the well-established health risks of prenatal and postpartum smoking a sizable number of pregnant women and new mothers smoke About 30 of US women who become pregnant smoke Only 20-40 of these women spontaneously quit upon learning of their pregnancy Although an additional 3-16 of pregnant smokers may quit later in pregnancy the majority continue to smoke throughout with 15-30 relapsing Research has also indicated that smoking cessation rates are lower among low-income pregnant women 6-14 versus more affluent populations Less educated lower SES unemployed women who have a higher addiction to nicotine are at greatest risk for smoking throughout their pregnancy while pregnant women with higher levels of education and income are more likely to quit These differential smoking rates result in elevated rates of high-risk pregnancies for low SES and less educated women vs higher SES and educated women While some research has demonstrated moderate success with prenatal smoking cessation interventions relapse remains a prominent concern Indeed more than a quarter of women who quit spontaneously relapse by 6-weeks postpartum with relapse rates reported as high as 60-80 by 6-months postpartum The highest relapse rates have been found among women with low income and little education
Smoking Cessation Interventions for Prenatal and Postpartum Women
To date the efficacy of available smoking cessation interventions has been disappointing The current literature on tobacco control indicates that cognitive-affective factors including perceived risk self-efficacy fatalism decisional balance and affect need to be considered when designing smoking cessation protocols Yet the behavioral treatments that have been tested for pregnant smokers focus on the use of self-help guides basic skills training and education neglecting the individuals cognitive-affective profile of barriers This limitation is paralleled by a similar void in the broader smoking cessation literature When these characteristics are addressed they have been considered in isolation without attention to the full spectrum of cognitive-affective barriers to quitting ie the interventions focus on only 1 barrier such as perceived risk or depression Not surprisingly among intervention studies with pregnant women only 3 produced quit rates above 20
Thus research now needs to build upon these guidelines to develop more potent smoking cessation interventions The design of our intervention is directly responsive to the call for the development of more creative and powerful behavioral interventions to replace the current best available programs Guided by the Cognitive-Social Health Information Processing C-SHIP model and based on our related behavior change protocols for low-income populations our approach is tailored to the womans cognitive-affective profile of barriers to initial and sustained uptake of smoking cessation
Determinants of Smoking Cessation Among Pregnant Women
The exploration of psychological factors as potential mediators of behavior change appears to be particularly promising The specific cognitive and affective processes proposed by the C-SHIP model as determinants of the uptake of individual health-protective behaviors eg smoking cessation include 1 perceived risk 2 self-efficacy and fatalistic beliefs 3 expectancies of consequences ie the pros and cons of cessation and 4 emotional distress Over the past decade a sizable literature has accumulated with respect to the psychological correlates of smoking behavior
Procedures and Interventions
Women who were between 1-25 weeks gestation were asked to participate in a study aimed at learning about smoking cessation techniques for quitting and relapse prevention Following recruitment and informed consent participants were randomly assigned to one of two groups which varied in intensity 1 the control group which provided a brief counseling of educational advice and assistance for quitting during each session or 2 a more intensive theoretically-guided smoking cessation intervention group based on the teams Cognitive-Social Health Information Processing Model C-SHIP which assessed and addressed the participants distinctive pattern of risk perceptions expectancies and beliefs and affective reactions Through prompts and role-play exercises in the context of in-person counseling potential barriers to cessation can be triggered in a safe supportive environment Baseline and follow-up assessments were conducted at 13-25 weeks gestation 26-38 weeks gestation 2-6 weeks postpartum and 20-22 weeks postpartum
Best Practice BP control condition consisted of two on-site 10-15 minutes sessions session 1 and 3 pick up a smoking cessation guidebrochure session 2 and receive an educational new letter by mail booster session CBC intervention included two 45 minutes on-site counseling sessions session 1 and 3 one 15-minutes on-site counseling session session 2 and one 15-minutes phone session booster session
Despite the well-established health risks of prenatal and postpartum smoking a sizable number of pregnant women and new mothers smoke About 30 of US women who become pregnant smoke Only 20-40 of these women spontaneously quit upon learning of their pregnancy Although an additional 3-16 of pregnant smokers may quit later in pregnancy the majority continue to smoke throughout with 15-30 relapsing Research has also indicated that smoking cessation rates are lower among low-income pregnant women 6-14 versus more affluent populations Less educated lower SES unemployed women who have a higher addiction to nicotine are at greatest risk for smoking throughout their pregnancy while pregnant women with higher levels of education and income are more likely to quit These differential smoking rates result in elevated rates of high-risk pregnancies for low SES and less educated women vs higher SES and educated women While some research has demonstrated moderate success with prenatal smoking cessation interventions relapse remains a prominent concern Indeed more than a quarter of women who quit spontaneously relapse by 6-weeks postpartum with relapse rates reported as high as 60-80 by 6-months postpartum The highest relapse rates have been found among women with low income and little education
Smoking Cessation Interventions for Prenatal and Postpartum Women
To date the efficacy of available smoking cessation interventions has been disappointing The current literature on tobacco control indicates that cognitive-affective factors including perceived risk self-efficacy fatalism decisional balance and affect need to be considered when designing smoking cessation protocols Yet the behavioral treatments that have been tested for pregnant smokers focus on the use of self-help guides basic skills training and education neglecting the individuals cognitive-affective profile of barriers This limitation is paralleled by a similar void in the broader smoking cessation literature When these characteristics are addressed they have been considered in isolation without attention to the full spectrum of cognitive-affective barriers to quitting ie the interventions focus on only 1 barrier such as perceived risk or depression Not surprisingly among intervention studies with pregnant women only 3 produced quit rates above 20
Thus research now needs to build upon these guidelines to develop more potent smoking cessation interventions The design of our intervention is directly responsive to the call for the development of more creative and powerful behavioral interventions to replace the current best available programs Guided by the Cognitive-Social Health Information Processing C-SHIP model and based on our related behavior change protocols for low-income populations our approach is tailored to the womans cognitive-affective profile of barriers to initial and sustained uptake of smoking cessation
Determinants of Smoking Cessation Among Pregnant Women
The exploration of psychological factors as potential mediators of behavior change appears to be particularly promising The specific cognitive and affective processes proposed by the C-SHIP model as determinants of the uptake of individual health-protective behaviors eg smoking cessation include 1 perceived risk 2 self-efficacy and fatalistic beliefs 3 expectancies of consequences ie the pros and cons of cessation and 4 emotional distress Over the past decade a sizable literature has accumulated with respect to the psychological correlates of smoking behavior
Procedures and Interventions
Women who were between 1-25 weeks gestation were asked to participate in a study aimed at learning about smoking cessation techniques for quitting and relapse prevention Following recruitment and informed consent participants were randomly assigned to one of two groups which varied in intensity 1 the control group which provided a brief counseling of educational advice and assistance for quitting during each session or 2 a more intensive theoretically-guided smoking cessation intervention group based on the teams Cognitive-Social Health Information Processing Model C-SHIP which assessed and addressed the participants distinctive pattern of risk perceptions expectancies and beliefs and affective reactions Through prompts and role-play exercises in the context of in-person counseling potential barriers to cessation can be triggered in a safe supportive environment Baseline and follow-up assessments were conducted at 13-25 weeks gestation 26-38 weeks gestation 2-6 weeks postpartum and 20-22 weeks postpartum
Best Practice BP control condition consisted of two on-site 10-15 minutes sessions session 1 and 3 pick up a smoking cessation guidebrochure session 2 and receive an educational new letter by mail booster session CBC intervention included two 45 minutes on-site counseling sessions session 1 and 3 one 15-minutes on-site counseling session session 2 and one 15-minutes phone session booster session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TURSG-02-227-01-PBP | OTHER_GRANT | American Cancer Society | None |